Ethical aspects

Participating institutions strictly comply with data protection laws and guidelines for safe and proper handling of sensitive personal information. Epidemiological and clinical research are developed in accordance with the ethical guidelines for epidemiological and clinical studies, respectively. Furthermore, each medical institution has an Ethical Review Board that examines and approves of research studies and protocols including the acquisition of informed consent, handling of specimen and personal information, and consideration for the sample contributors in genetic research.

Security measures

The Academic Section and Research Institute for Information Technology of Kyushu University in collaboration with NTT Data Corporation has completed the database system, and continues to monitor it to ensure the highest level of information security in network communications and data storage facilities.

The specimens used for analysis are stored under strict control. When a patient requests for the destruction of the contributed samples, proper disposal will be done.

Personal information protection

In the prospective study, all information about the consenting patients, such as medical records, prognostic investigation, and specimens (e.g., plasma aliquots, DNA samples, etc.) are de-identified. Patient details, such as name, address, and contact number, are removed from the samples. Each sample is assigned a unique code so that it is unrecognizable. The reference tables containing codes and their corresponding samples are strictly controlled by the personal information administrator of the Department of Medical Informatics (Kyushu University Hospital). Information is entered into the database under stringent control. FSR will ensure that no personally identifiable information can be found in the study.

If there is a need to communicate with the patient (e.g., to explain analysis results), the personal information administrator will allow limited access to pertinent data to facilitate retracing. In the case of surveys for prognosis (i.e., to check on the patient’s health condition after discharge), the researcher-in-charge in the medical institution where the patient was admitted may use the patient’s details to contact him or send the informed consent form to his family physician to obtain detailed clinical information. For purposes of audit and postings, the medical records may be viewed by a third party, such as the Clinical Research Coordinator (CRC) who supports the research. In this case, the third party is bound to the terms of confidentiality agreement to protect a patient’s personal information. 

Correlation analysis of genetic and clinical information is done in the main research institution (Kyushu University). Further stringent safety control measures in protecting information are provided. In this study, however, the management of data analysis, diagnostics, including DNA studies, and other related items may be outsourced to a third party. Information is kept de-identified. Provisions are made to secure the contract with the consignees so that patients do not have to worry about data leakage.

We seek your consent and cooperation upon hearing our full explanation on this matter.